Law Summary
Objectives
- Adopt FAO-published risk-based classification of food establishments and products.
- Issue License to Operate (LTO) for establishments involved in manufacturing, processing, or distributing food products.
- Issue Certificate of Product Registration (CPR) to FDA-licensed establishments before marketing processed foods.
Scope and Coverage
- Covers food establishments manufacturing, distributing (import, export, wholesale), trading, or repacking processed foods.
- Excludes fresh/raw food under Department of Agriculture's jurisdiction and certain food businesses regulated by Local Government Units (LGUs), such as wet markets and restaurants.
Key Definitions
- Activity: Includes processing, packaging, repackaging, trading, import, export, sale, promotion of food.
- Authorization: Regulatory approval in forms such as permits, licenses, certificates.
- Food: Any substance intended for human consumption including drinks and additives.
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), HACCP defined as standards for ensuring product quality and safety.
- Manufacturer, Distributor, Trader roles distinguished with specific operational scopes.
- Labeling, Advertising, Import, Export, Packaging, Repackaging clarified.
Licensing of Food Establishments - General Principles
- FDA issues LTO based on risk classification consistent with FAO guidelines; high-risk establishments prioritized for inspection.
- A single LTO may cover multiple related activities depending on compliance capability.
- Application requires full submission of prescribed documents; LTO is prerequisite to CPR application.
- Compliance with GMP, GDP, HACCP and other standards mandatory.
- Only one licensed establishment per address is allowed; sharing among different activities or owners is prohibited.
- Licensed establishments must display LTO conspicuously.
- Fees required for application, changes require prior notification and amendment approval.
- Violation can result in revocation and prohibition from re-applying for three years.
- Compliance with related laws such as ASIN Law and Food Fortification Act mandatory.
Specific Guidelines for Manufacturers and Traders
- Single LTO may cover different facility locations for the same product.
- Separate licenses required for different products or stages in different locations.
- No shared facilities allowed for manufacturing.
- Manufacturers can import raw materials for own use, subject to specific fortification and labeling laws.
Specific Guidelines for Distributors (Importers, Exporters, Wholesalers)
- No shared offices between establishments regardless of ownership.
- Must declare warehouses and depots.
- Distributors may engage in manufacturing/repacking only with additional LTO.
- Exporters must adhere to importing country’s requirements.
Requirements for Licensing
- Detailed requirements outlined in Annex C of the Administrative Order.
Validity of License to Operate (LTO)
- Initial license valid for 2 years.
- Renewal valid for 5 years.
Application Process
- Issuance of Certificate of Compliance (COC) after inspection.
- FDA Regional Field Office can disapprove applications citing reasons.
- Notice of disapproval must state grounds clearly.
Registration of Processed Food Products - General Principles
- All processed foods, additives, supplements, and bottled water must be registered with FDA before marketing.
- Single CPR covers multiple package sizes or label designs given consistency in brand, product name, formula, and labeling (except net weight).
- Any label redesign requires prior FDA notification.
- Non-compliant products receive Letter of Denial; 6-month period to comply and reapply.
- Importers or distributors must secure CPR for raw materials and additives intended for sale or distribution.
- Manufacturers importing raw materials for their own use need not secure separate CPR for those materials.
- Exported products must comply with standards and labeling of importing country.
Quality and Safety Standards
- Registration based on compliance with food safety, quality standards and labeling requirements, including adherence to codes like GMP, HACCP, GDP.
- Compliance with ASIN Law, Food Fortification Law, and other relevant laws required.
- Submission of Certificate of Analysis (COA) mandatory for products under separate laws as applicable.
Product Claims and Labeling
- Clear labels required; food supplements cannot carry curative or therapeutic claims.
- Advertising must avoid unsubstantiated health claims.
Registration Requirements and Validity
- Detailed in Annex D.
- CPR valid between 2 to 5 years initially; 5 years upon renewal.
Registration Process
- FDA reviews compliance, may conduct inspections or require additional documents for high-risk products.
- Letter of Denial issued for non-compliance; 6 months allowed to cure deficiencies.
Inspection and Certificate of Compliance
- Inspections risk-based; FDA may collaborate with LGUs and other agencies.
- Pre-licensing inspections lead to issuance of COC.
- Microenterprise inspection may rely on LGU-issued sanitary permits and health certificates.
- FDA reserves right for routine, spot-check, or complaint-driven inspections.
- FDA may revoke LTO or CPR upon validation of non-compliance following due process.
Grounds for Disapproval of Applications
- Incomplete or incorrect documents.
- Failure to meet standards or pass facility inspection.
- Failure to timely respond to deficiency notices.
- Misrepresentation or withholding relevant data.
- Other analogous grounds as determined by FDA.
Fees and Charges
- Application and renewal fees as per existing regulations for fees and charges.
Post-Market Surveillance and Product Monitoring
- FDA conducts ongoing product sampling and establishment inspections based on risk.
- Foodborne illness data collection supports risk management.
- Risk communication and mandatory food safety training enhance compliance.
Transition Period
- Six months to streamline licensing and registration systems with other government bodies after enactment.
Separability Clause
- Invalidity of any provision does not affect the rest of the Order.
Repealing Clause
- Previous inconsistent issuances and regulations are withdrawn or revoked.
Effectivity
- Effective 15 days after publication in official gazette or newspaper of general circulation.